Apparatus and methods for accessing and sealing bodily vessels and cavities

ABSTRACT

Everting balloon systems and methods for using the same are disclosed herein. The systems can be configured to access and dilate body lumen and cavities. For example, the systems can be used to dilate the cervix and access the uterine cavity. The systems can also be used to occlude the cervix. The systems can also be used to occlude the urethra.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 15/690,096, filed Aug. 29, 2017, issued as U.S. Pat. No.9,949,756, which is a continuation of U.S. patent application Ser. No.14/525,043, filed Oct. 27, 2014, which claims priority to U.S.Provisional Application Nos. 61/902,742, filed Nov. 11, 2013,61/977,478, filed Apr. 9, 2014; 62/005,355, filed May 30, 2014; and62/007,339, filed Jun. 3, 2014, all of which are incorporated byreference herein in their entireties.

BACKGROUND

For physicians and medical professionals, accessing systems for vesselsand bodily cavities in patients have typically used various guidewireand catheter technologies. In some cases, the process requires theinsertion of a series of mandrels or wires to increase the lumendiameter for the eventual passage of a larger bore instrument within thevessel. This technique can be referred to as “Dottering” or in the caseof accessing the cervical canal and uterus, physicians will use a seriesof increasing diameter mandrels known as Hegar dilators. In thetechniques described above, the methods involved pushing an object,mandrel, or device through the vessel to gain access to a desired regionin the body. The result of pushing an object, mandrel, or device createsshear forces on the lumen wall. In some cases the shear forces canresult in trauma, pain for the patient, or perforation.

In contrast, another access technology that has been used in prior artis referred to as an everting catheter. Everting catheters utilize atraversing action in which a balloon is inverted and with the influenceof hydraulic pressure created by a compressible or incompressible fluidor media, rolls inside out or everts with a propulsion force through thevessel. Everting balloons have been referred to as rolling or outrollingballoons, evaginating membranes, toposcopic catheters, or lineareverting catheters such as those in U.S. Pat. Nos. 5,364,345; 5,372,247;5,458,573; 5,472,419; 5,630,797; 5,902,286; 5,993,427; 6,039,721;3,421,509; and 3,911,927; all of which are incorporated herein byreference in their entireties. These are categorized as evertingballoons and are for traversing vessels, cavities, tubes, or ducts in africtionless manner In other words, an everting balloon can traverse atube without imparting any shear forces on the wall being traversed.Because of this action and lack of shear forces, resultant trauma can bereduced and the risk of perforation reduced. In addition as a result ofthe mechanism of travel through a vessel, material and substances in theproximal portion of the tube or vessel are not pushed or advancedforward to a more distal portion of the tube or vessel.

In addition, as the everting catheter deploys inside out, uncontaminatedor untouched balloon material is placed inside the vessel wall. In theinverted or undeployed state, the balloon is housed inside the catheterbody and cannot come into contact with the patient or physician. As theballoon is pressurized and everted, the balloon material rolls insideout without contacting any element outside of the vessel. Anotheradvantage of an everting balloon catheter is that the method of accessis more comfortable for the patient since the hydraulic forces “pull”the balloon membrane through the vessel or duct as opposed to a standardcatheter that needs to be “pushed” into and through the vessel or duct.

The method typically used by physicians for accessing the cervical canalin women requires the use of multiple instruments of increasingdiameter. The physician will use a small uterine sound or small diameterprobe or Hegar device for gaining initial entry into the uterus via thecervix. Ever increasing sizes of Hegars are used to stretch the cervicalmuscles until the desired internal diameter is achieved for theinsertion of a secondary instrument such as an endoscope or otherdevice. This process can be particularly difficult in some nulliparous,post-menopausal women with very small diameter cervical canals. A cervixcould be difficult to traverse as a result of prior surgery, underlyingstenosis, or other anatomical configuration or tortuosity that makes thepassage of instruments or Hegar dilators difficult.

There are some cervical dilators that provide radial expansion to openthe cervical canal to a greater internal diameter without the insertionof multiple instruments. All of these devices are predicated on firstcrossing or traversing the cervical canal prior to the step of radialexpansion. Once traversed through the cervical canal, these devices useeither mechanical means or the expansion of a balloon dilation memberthat is concentric on the exterior of the dilator probe. If the cervicalcanal is particularly tight or narrow, a small diameter probe or mandrelmay be required to first cross the cervix and access the uterine cavity.As mandrels or instruments get smaller in diameter, the likelihood ofperforation or a false passage increases. In any case, these cervicaldilators require passage or crossing by the initial probe prior to anyfurther radial expansion being performed.

Everting catheters have been described as dilatation catheters.Representative examples of dilating everting catheters include U.S. Pat.Nos. 5,364,345 and 4,863,440, both of which are incorporated byreference herein in their entireties.

Everting catheters have also been described with additional elementssuch as a handle for controlling instruments within an evertingcatheter. A representative example is U.S. Pat. No. 5,346,498 which isincorporated by reference herein in its entirety. Everting ballooncatheters can be constructed with an inner catheter with an internallumen or through-lumen (or thru-lumen). The through-lumen can be usedfor the passage of instruments, media, materials, therapeutic agents,endoscope, guidewires, or other instruments. Representative samples ofeverting catheters with through-lumens are in U.S. Pat. No. 5,374,247and 5,458,573. In addition, everting catheters have been described withwaists or a narrowing of the balloon diameter, such as in U.S. Pat. No.5,074,845, which is incorporated by reference herein in its entirety.

Furthermore, infertility is a condition that affects 1 out of 8 couplesin the US. One of the early treatments in the infertility regime isinsemination. Intrauterine insemination or IUI is a very commonprocedure since it is in the early work up of an infertile couple. Mostassisted reproductive clinics perform at least 3 IUI cycles beforetrying more expensive treatment options such as IVF. IUI cycles may becoupled with drugs to stimulate greater ovulation to improve the chancesor likelihood of pregnancy. Sperm that is collected from the male istypically washed and prepared prior to an insemination through acatheter with the goal of providing a greater volume or amount of viablesperm in the uterine cavity and into the reproductive tract of thefemale.

As part of increasing the odds of getting pregnant, physicians have beenusing a variety of means of increasing both the amount of sperm and theduration sperm could be in the uterine cavity. To keep sperm fromexiting the cervical canal after insemination, physicians have usedrubber and silicone based cervical caps that are designed to fit overthe exocervix as a sealing member. In practice, a physician will eitherinseminate the uterine cavity or fill the cervical cap with sperm andthen fit over the cervix as a seal. The security of the cervical cap isnot reliable and due to its size and bulk, not as comfortable for thepatient. Typically a cervical cap will only be used by the patientwithin the physician's office for a predetermined amount of time. Theoverall objective of the cervical cap is to keep sperm in the uterinecavity for as long as possible without being expelled or spilling fromthe cervix due to gravity or contractions of the uterus. Ideally thesperm will migrate upward through the fallopian tubes to the fimbriawhere conception can occur if an oocyte from an ovary is present. Manyclinical investigations have reported that, once through the fallopiantubes, sperm can travel throughout the peritoneal cavity and stay viablefor many hours in situ. Equally, sperm can stay viable in a controlledenvironment or an incubator for many hours.

Another methodology for keeping sperm in the uterine cavity is done byuse of a pump connected to a catheter within the uterine cavity. A pumpthat can be worn by the women or keep bedside is filled with sperm andis pumped through the catheter at a rate pre-set by the physician. Forinstance, the pump can be set to run for 2 to 6 hours at which sperm ispumped through the catheter and into the uterine cavity. The pump can beworn by the woman outside of the physician's office but patient mobilityis limited due to keeping the integrity of the conduit and pump.

Also, when delivering the reproductive material, such as an embryo, intothe uterine cavity, vacuum effect can unintentionally remove thereproductive material from the uterine cavity. In existing systems, whenthe transfer catheter is retracted from a second outer or guidingcatheter (e.g., the “inner” catheter), the retraction produces vacuumpressure within the uterine cavity. This vacuum pressure is created inthe uterine cavity by the removal and backward movement of the transfercatheter within the inner catheter. After the embryo transfer iscompleted, an embryologist may inspect the transfer catheter to verifythat the embryos or reproductive material was indeed deposited in theuterus and not pulled back into the transfer catheter because of thevacuum effect. The same procedure may be done for the outer catheteronce this catheter is removed.

Further, incontinence is a prevalent clinical and social issue thatprimarily affects women. Various publications estimate the percentage ofwomen with urinary incontinence from 15 to 30% in the over 60 age group.The amount spent treating incontinence ranges from S3 to 5B annually inthe US. Urinary Incontinence is one of the 10 most common chronicconditions in the US with over 15M women diagnosed in the US alone. Mostfeel that this number is under-reported. The choice of therapeuticoptions has limited reimbursement and many of the techniques lackconsistent data. As an example, invasive approaches in women includesuspensions of the bladder neck, collagen injections, and RF remodeling.Incontinence is a multi-factorial disease condition and patientsatisfaction with many invasive techniques is poor. For patients,surgery is the last preferred resort. Noninvasive techniques includebiofeedback and Kegel exercisers. These techniques improve the muscletone in the patient's pelvic floor but they rely on patient complianceto be effective. Less invasive options involve mechanical pressuredevices such as pessaries, urethral catheters or inserts, and patchesover the urethral opening. Most incontinence money is expended onpurchase of absorbent products. Due to the social stigma, many patientsare reluctant to seek advice and many patients decline surgical and lessinvasive options. Consequently, male and female incontinence patientsrely on sanitary pads and the restrictions that the presence of bulky,wet pads imposes on their daily lives.

In some patients, a urethral insertable device for sealing is thepreferred method for managing their incontinence. These inserts aredesigned for single use and are self-applied. Typically they rely on themeasurements of urethral length for insertion and balloon inflation.

Urethral inserts are plugs that typically incorporate a balloonmechanism to create a seal in the urethra or bladder. For voiding, theballoon is deflated. These devices have been described previously in theart including U.S. Pat. No. 5,090,424; 5,483,976; 5,724,994; 5,752,525;and 5,769,091 all attributed to Simon et al. Additional art is found inU.S. Pat. No. 5,806,527; 6,449,060; 6,926,708; EP 0900058 B1, and EP1365713 B1. U.S. Pat. No 5,927,282 to Lenker et al describes an adhesivepatch for covering and sealing the urethral opening and sealing theexternal opening to the urethra.

Further art includes U.S. Pat. No. 5,662,582 which describes an evertingurethral plug with an invaginating balloon mechanism. Everting balloonsdescribe an action in which a balloon is inverted and, with theinfluence of hydraulic pressure created by a compressible orincompressible fluid or media, rolls inside out or everts with thatpropulsion force. Everting balloons have been referred to as rolling oroutrolling balloons, evaginating membranes, toposcopic catheters, orlinear everting balloons. These are all categorized as everting balloonsdue to their property of traversing vessels, cavities, tubes, or ductsin a substantially frictionless manner Everting balloons can traverse atube without imparting any significant shear forces on the wall beingtraversed. Because of this action and lack of shear forces, material andsubstances in the proximal portion of the tube or vessel are pushed oradvanced forward to a more distal portion of the tube or vessel. Forexample for urethral everting balloons, potentially infectioussubstances from the vagina, urethral openings, or the hands of thepatient, are not in contact with the everted balloon that resides in theurethra. In contrast, urethral plugs and inserts in use currently have apropensity of urinary tract infections which may be a result of the lackof cleanliness of the device that resides in the urethra or bladder.

This methodology would be more widely adopted if the inserts were morecomfortable while wearing, had less of a foreign body sensation, andwere easier to use or insert. More significantly, many patients who areinsert users complain of higher incidence of urethral infection andsoreness at their urethra and groin region, especially with increasedactivity, which is the ideal time the user would want the insert tooperate properly.

For a patient, being able to insert a device within their own urethra isnot easy and the act itself is unnatural for the patient. Training by anurse or physician is required for a patient to master the technique.Since the inserts used today require pushing a device through theurethra, the urethral passageway could become sore or tender afterrepeated insertions.

Current urethra inserts are typically sized to match the length of thepatient's urethra, not as a “one size fits all.” Current inserts need tocreate a balloon seal at the bladder coupled with a compressive force atthe urethral opening. Thus the insert length is calculated by soundingthe length of the urethra by a probe or via ultrasound measurement. Thecalculation is designed to hold the balloon taut against the opening ofthe bladder and the compressive force of the external portion of theinsert of the opening of the urethra. Hence it is understandable thatthe presence of a relatively stiff device that is keeping the opening ofthe bladder tight against the urethral opening can create anuncomfortable feeling for the patient, especially a patient that isactive and mobile.

Furthermore, urinary protection and voiding could occur 3 to 7 times aday, a high cost device would not be acceptable to most patients orwould limit the device usage to only the most socially challengingevents.

SUMMARY OF THE INVENTION

An everting balloon system is disclosed. The everting balloon system canbe used for insemination, urinary incontinence, dilation of a bodylumen, for access and sealing within a body cavity, or combinationsthereof. The system can have automatic disengagement. The system canhave a handle for insertion. The system can have a motorized air pump.The system can have inner and outer catheters that can automaticallydisengage upon everting.

The everting balloon system can have deflation and removal mechanisms ofa device that can be worn by a mobile patient in a body lumen (e.g.,cervical canal or urethra) and be deflated and removed by the patient.

The everting balloon system can have an intubating base with a lockingballoon that can activate upon pressurization. The system can be acompact, low profile unit used in vivo. The system can be single use anddisposable. The system can be non-irritation and non-infection causing.

The everting balloon system can be used for cervical access anddilation. The everting balloon system can have a system handle mechanismthat can enable a one-handed operating technique by the user. Theone-handed operating technique can include advancement andpressurization of the everting balloon membrane within the control ofthe user with one hand.

The everting balloon system can be used for insemination and can sealthe cervix for a duration of time for the deposition of sperm and toallow for mobility for the patient. The everting balloon system can havea decoupling mechanism configured to decouple the outer catheter andinner catheter while maintaining hydraulic pressure in an evertingballoon. The system can deflate and removal the everting balloonconcurrently.

The system can be used to place or deliver fallopian tube inserts (i.e.,intratubal inserts, such as the Essure device from Bayer Corporation) infallopian tubes. The system can access the intramural and isthmicportions of the fallopian tube. All or part of the everting cathetersystem can be loaded into a hysteroscope and placed with directendoscopic visualization.

The everting catheter system can be a selective fallopian tube catheterwith a curved distal end section and angled ball tip. This configurationcan be performed by ultrasound or radiographic visualization.

One or more fallopian tube occluding devices (e.g., the Essure device)can be loaded into the everting balloon system, for example, in thethrough lumen of the inner catheter. Once fully everted and placed intothe fallopian tube, the everting balloon system, such as the innercatheter, can be withdrawn from the fallopian tube while leaving thefallopian tube occluding device in the fallopian tube. Once the evertingballoon system is withdrawn from the fallopian tube, the fallopian tubeoccluding can be deployed (e.g., device anchors such as coils can beextended, or a resilient porous matrix can expand to friction fit thetube lumen). Once the fallopian tube occluding device is deployed, acentral guidewire can be removed from the fallopian tube. The procedurecan be repeated for the contralateral fallopian tube.

The everting balloon system can be used to access the bladder, ureters,kidneys, or combinations thereof. Devices, tools, instrumentation,endoscopes, drugs, therapeutic agents, sampling devices (brushes,biopsy, and aspiration mechanisms), or combinations thereof can bedelivered through the inner catheter lumen to the target site.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A through 1E are longitudinal cross-sectional views of the distalend of a variation of a method for using the everting balloon system.

FIG. 2A illustrates a variation of the everting balloon system in afully everted configuration.

FIG. 2B is a cross-sectional view of a variation of the system handle.

FIG. 3A illustrates a variation of the distal end of the evertingballoon system with the dilating balloon in a less than fully inflatedconfiguration.

FIG. 3B illustrates a variation of the distal end of the evertingballoon system with the dilating balloon in a fully inflatedconfiguration.

FIG. 4A illustrates a variation of the everting balloon system with asyringe in an attached, but not yet deployable configuration.

FIG. 4B illustrates a variation of the everting balloon system with thesyringe in an attached and deployable configuration.

FIG. 4C illustrates a variation of the everting balloon system of FIG.4B with the plunger driver shown in cut-away.

FIG. 5A illustrates a length of a variation of the everting balloonsystem.

FIG. 5B is a partial cross-sectional view of a variation of the systemof FIG. 5A.

FIGS. 5C and 5D are variations of side and perspective views of aportion of cross-section A-A.

FIG. 5E is an exploded view of a variation of a portion of the systemhandle and the drive gears.

FIG. 5F is a close-up view of a variation of the system handle at theratchet handle axle.

FIG. 6A is a cross-sectional view of a variation of the system handle.

FIGS. 6B through 6D are side, top perspective and cross-sectional views,respectively, of a variation of the everting balloon system with thesystem handle of FIG. 6A.

FIGS. 7A and 7B are exploded and perspective views, respectively, of avariation of the everting balloon system.

FIG. 8A is a cross-section view of a variation of the three-wayconnector and adjacent elements in a configuration to deliver mediapressure to the outer catheter, for example to the everting balloon.

FIG. 8B is a cross-section view of a variation of the three-wayconnector and adjacent elements in a configuration to deliver mediapressure to the inner catheter, for example to the dilating balloon.

FIG. 9 is an exploded view of a variation of a transfer catheter.

FIGS. 10A through 10C illustrate a variation of method for deliveringmaterial to a target site, such as reproductive material delivered to auterine cavity.

FIGS. 11A through 11C illustrate a variation of a method for deliveringmaterial to a target site, such as reproductive material delivered to auterine cavity.

FIG. 12A is a longitudinal cross-sectional view of a variation of thedistal end of the everting balloon system.

FIGS. 12B and 12C are close-up section A-A of the system of FIG. 12Awith the outer catheter in configurations attached to the distal closuretip and detached from the distal closure tip, respectively.

FIG. 13A is a cross-section view of a portion of a variation of theeverting balloon system in a retracted configuration.

FIG. 13B is a cross-section view of a portion of a variation of theeverting balloon system in an extended or everted configuration.

FIG. 13C illustrates a variation of a method for removing the evertingballoon from a body lumen.

FIG. 14A illustrates a variation of a portion of the everting balloonsystem with the plug inserted in the outer catheter distal tip.

FIG. 14B illustrates the variation of the portion of the evertingballoon system from FIG. 14A with the plug not inserted in the outercatheter distal tip.

FIGS. 15A illustrates a variation of a portion of the everting balloonsystem with the plug not inserted in the outer catheter distal tip andthe everting balloon in a retracted configuration.

FIGS. 15B and 15C illustrate the variation of the portion of theeverting balloon system of FIG. 15A with the plug inserted in the outercatheter distal tip and the everting balloon in a retractedconfiguration.

FIGS. 16A and 16B illustrate a variation of a portion of the evertingballoon system with the everting balloon in everted and retractedconfigurations, respectively.

FIG. 17 illustrates a variation of a method for pressurizing theeverting balloon.

FIGS. 18A and 18B illustrate a variation of a method for pressurizingthe everting balloon.

DETAILED DESCRIPTION

An everting balloon system 2 (also referred to as an everting cathetersystem) that can be used to traverse a vessel, such as the cervicalcanal is disclosed. The everting balloon system 2 can be used to accessthe uterine cavity via the cervix. The cervical canal is a single lumenvessel that can stretch or dilate. The everting balloon system 2 canhave a control system that can be operated with one hand.

FIGS. 1A through 1E illustrate that an everting catheter system 2 canhave a radially outer catheter 4, a balloon membrane 6, and a radiallyinner catheter 8. The inner catheter 8 can have an inner catheter lumen10 (e.g., a through-lumen). The distal end of the inner catheter lumen10 can be open or closed. The inner catheter 8 can have the innercatheter lumen 10 or be a solid rod or flexible mandrel. The evertingballoon system 2 can have a media volume 12. The media volume 12 can bethe contiguous open volume between the inner catheter 8 and outercatheter 4 that is proximal to the balloon membrane 6. A radially outerterminal perimeter of the balloon membrane 6 can be attached to thedistal terminal end of the outer catheter 4. A radially inner terminalperimeter of the balloon membrane 6 can be attached to the distalterminal end of the inner catheter 8. The everting balloon system 2 canbe made without an inner catheter 8, for example with the balloonmembrane 6 extending proximally out of the working area to a controldevice (e.g., a pump).

FIG. 1A illustrates that the everting catheter system 2 can be in anunpressurized configuration. The media volume 12 can be uninflated andunpressurized. The balloon membrane 6 can be slack.

FIG. 1B illustrates that that everting catheter system 2 can be in apressurized and uneverted configuration. A pressurization device, suchas a pump, for example at the proximal end of the everting cathetersystem 2 can be in fluid communication with the media volume 12. Thepressurization device can deliver a fluid media, such as a pneumatic gasor hydraulic liquid media (e.g., saline, water, air, carbon dioxide, orcombinations thereof), at a media pressure 14 to the media volume 12.The media pressure 14 in the everting balloon 2 can be from about 2 toabout 5 atmospheres of pressure when in the everted configuration andhigher media pressures 14 from about 5 atmospheres to 10 atmospheres arepossible, for example, to provide greater everting capability for moredifficult or stenotic passageways in the body.

The balloon membrane 6 can inflate and be in tension. The balloonmembrane 6 can block the distal port of the inner catheter lumen 10.

FIG. 1C illustrates that the everting catheter system can be in aninflated and partially everted configuration. The inner catheter 8 canbe translated distally, as shown by arrow 16, with respect to the outercatheter 4, and out of the outer catheter 4. The distal terminal end ofthe inner catheter 8 can be proximal of the distal terminal end of theballoon membrane 6. The distal terminal end of the inner catheter 8 canbe proximal or terminal of the distal terminal end of the outer catheter4. The balloon membrane 6 can block the distal port of the innercatheter lumen 10 or can be open allowing fluid communication betweenthe inner catheter lumen 10 and the target site.

FIG. 1D illustrates that the everting catheter system can be in aninflated, fully everted, and fully distally extended configuration. Theinner catheter 8 can be translated distally, as shown by arrow 16, withrespect to the outer catheter 4 until the distal terminal end of theinner catheter 8 is longitudinally beyond or co-terminal with the distalterminal end of the balloon membrane 6. The distal port of the innercatheter lumen 10 can be unobstructedly accessible and in fluidcommunication with the target site.

In the fully inflated configuration, the balloon membrane 6 can form aninflated everting balloon 18. The everting balloon 18 can have a balloonouter diameter 20 and balloon length 22 in the inflated and fullyeverted configuration.

The balloon outer diameter 20 can be from about 2 mm to about 20 mm,more narrowly from about 2 mm to about 7 mm, for example about 5 mm Theouter diameter can be constant or vary along the length of the evertingballoon 18. For example, for use in the cervical canal, the mostproximal portion of the everting balloon outer diameter 20 could beconfigured with a smaller outer diameter than the remainder of theeverting balloon membrane 24. As an example, the first proximal portionof the everting balloon 18 can have a smaller balloon outer diameter 20such as from about 2 mm to 4 mm for a length of from about 5 mm to about10 mm from the distal terminal end of the outer catheter 4, and theremainder of the length (e.g., from about 4 cm to about 7 cm along theeverting balloon 18) of the everting balloon 18 can have a balloon outerdiameter 20 from about 4 mm to about 7 mm The outer diameter of theproximal end of the everting balloon 18 can have a consistent balloonouter diameter 20, for example for delivery in the urethra, of fromabout 3 mm to about 6 mm, and the distal-most outer about 2 cm to about3 cm of the everting balloon 18 can have a balloon outer diameter 20from about 10 mm to about 20 mm, for example to create a seal with andanchor in the bladder.

The exterior surface of the balloon membrane 6 can be configured withridges, projections, bumps, grooves, and additional surface ormechanical features, or combinations thereof, for example for increasedfriction or holding power within the vessel.

The everting balloon length 22 can be from about 2 cm to about 31 cm,more narrowly from about 2 cm to about 25 cm (e.g., for use in a maleurethra), yet more narrowly from about 2 cm to about 7 cm, yet morenarrowly from about 3 cm to about 6 cm, for example about 4 cm, about 7cm, about 15 cm and about 30 cm.

FIG. 1E illustrates that the everting catheter system can be in aninflated and partially or fully everted configuration. A tool 26,liquid, gas, or combinations thereof can be translated, as shown by thearrow 28, through the inner catheter lumen 10, out of the distal port ofthe inner catheter lumen 10 and into the target site. The tool 26 can bea biopsy tool, a scope, a sonogram probe, a plug, a cauterization tool,or combinations thereof. Suction can be applied from the proximal end ofthe inner catheter lumen 10, and to the target site, for exampleremoving debris from the target site through the inner catheter lumen10.

To retract and reposition or remove the balloon membrane 6, the innercatheter 8 can be pulled proximally to pull the balloon membrane 6 backwithin the outer catheter 4. The balloon membrane 6 can be deflated orhave media pressure 14 reduced and the entire system can be withdrawnfrom the target site.

FIG. 2 illustrates that the everting balloon system 2 can have a systemhandle 30. The system handle 30 can have a system handle connector 32.The system handle 30 can be attached to the outer catheter 4 and theinner catheter 8, for example at the system handle connector 32. Thesystem handle connector 32 can be removably attached to the outercatheter 4. For example, the outer and inner catheters 4, 8 and balloonscan be detached from the system handle 30 and replaced. The systemhandle 30 can be sterilizable. Media (e.g., liquid or gas) delivered bythe system handle 30 can be filled into the system handle 30 beforeattaching or replacing the catheters and balloons.

The system handle 30 can have a rigid system handle case 34 and a rigidpump lever 36 rotatably attached to the system handle 30 case at a pumplever axle 38.

The system handle 30 can have an inlet port 40. The everting balloonsystem 2 can have a pressurization source. The pressurization source canhave a flexible liquid reservoir 42 or fluid supply container or bag.The fluid bag can be filled with a hydraulic and/or pneumatic fluid.

The inlet port 40 can be a female luer fitting and connection. The inletport 40 can be in fluid communication through an inlet-reservoir channel44 with the flexible reservoir 42. The liquid reservoir 42 can bebetween the rigid pump lever 36 and a rigid system handle case 34. Theinlet port 40 can extend out of the proximal end of the system handlecase 34. The inlet port 40 can be configured to attach to a liquidsource (e.g., a hose, tube, or supplemental reservoir configured todeliver the liquid through the inlet port 40 and to the liquid reservoir42). The inlet port 40 can have a proximal check valve or one-way valveconfigured to allow flow to the liquid reservoir 42 and prevent backflow(e.g., proximal flow from the liquid reservoir 42 and out the inlet port40).

The liquid reservoir 40 can be in one-way (e.g., via a check valve) ortwo-way fluid communication with the media volume 12.

When the liquid reservoir 42 contains liquid, the pump lever 36 canrotate away from the system handle case 34, as shown by pump leverrotation arrows 46, as the liquid reservoir 42 inflates. The pump lever36 can be rotated toward the system handle case 34 to compress theliquid reservoir 42, for example, forcing liquid from the liquidreservoir 42 and into the media volume 12 of the everting balloon 18.

The pump lever 36 can provide a pumping (e.g., suction) action to supplyaspiration to withdraw liquid from the media volume 12 of the evertingballoon 18. A spring within the lever can facilitate the pumping actionof the lever to open the lever (not shown) for each compression.

The system handle 30 can have an advancement slide 48. The advancementslide 48 can be proximally and distally translatable, as shown by arrow50, with respect to the system handle case 34. The advancement slide 48can be configured to translate the inner catheter 16 with respect to theouter catheter 4. For example, pushing the advancement slide 48 distallycan push the inner catheter 8 distally with respect to the outercatheter 4 and evert the everting balloon 18. Pulling the advancementslide 48 proximally can pull the inner catheter 8 proximally withrespect to the outer catheter 4 and retract the everting balloon 18. Theadvancement slide 48 can have gear wheels, ratchets with racks, androtating advancement screws.

The advancement button can be an advancing ratchet or a roller wheelthat is geared into or with the inner catheter 8 to allow fortranslation of the inner catheter 16.

With one hand, the physician can advance the inner catheter 8, evert theeverting balloon 18, traverse the cervical canal with the evertingballoon 18, and access the uterine catheter through the inner catheterlumen 10.

The fluid reservoir 42 can be pressurized prior to placement of thedistal tip of the outer catheter 4 at the cervix. The fluid reservoir 42can has a proximal check or one-way valve on the proximal portion of thehandle. The proximal check valve is the connection point for thephysician to pressurize the system. The distal portion of the fluid bagcan be attached to a distal pressure check valve 52 that can open whenpressure from the fluid bag is at or above a distal check valve limitpressure, for example about 1 atmosphere of pressure from the liquidreservoir, and then deliver liquid and pressure from the liquidreservoir 42 to fill and pressurize the media volume 12 of the cathetersand everting balloon 18. The distal pressure check valve 52 can be aone-way valve allowing hydraulic or pneumatic fluid or media to go fromthe fluid reservoir 42 to the media volume 12 of the catheters andeverting balloon 18. Higher and lower atmosphere pressure ratings from 1atmosphere are also possible for the distal pressure check valve 52 suchas from about 0.5 atmospheres to about 2 atmospheres.

During pressurization of the fluid reservoir 42 (e.g., by pumping withthe pump lever 36 or from the inlet port via the proximal check valve54), pressures greater than a reservoir limit pressure (e.g., 1atmosphere) of the distal pressure check valve 52 can open the distalpressure check valve 52 and allow fluid media to flow from the liquidreservoir 42 into the media volume 12 of the catheters and evertingballoon 18. The pressurization in the media volume 12 of the cathetersand everting balloon 18 can unroll and evert the everting balloon 18under hydraulic force. Excess media can remain in the fluid reservoir 42after the everting balloon 18 fully everts.

The distal pressure valve 52 can be connected to a three-way connector56 (e.g., Y-connector or T-connecter) that has a hemostasis valve 58,for example a Touhy-Borst valve. Thus the fluid reservoir 42 can stageor hold additional potential hydraulic pressure to be stored in thesystem for the user (e.g., physician) to use as needed by rotating thepump lever 46 without a change of hand position or the use of a secondhand.

The inner catheter 8 can extend through the three-way connector 56. Theinner catheter 8 can translate (i.e., advance and retract) through thethree-way connector 56 while maintaining a seal (i.e., without the mediavolume 12 of the catheters or everting balloon 18 losing pressure). Theinner catheter 8 (e.g., if a solid rod or mandrel) can be configured towithstand hydraulic pressures of up to about 5 atmospheres or up toabout 10 atmospheres during the everting process and translational(e.g., advancement, retraction, tensile, compression, or combinationsthereof) forces of up to about 2 pounds or up to about 5 pounds withoutdeformation. As an example, during the everting process the innercatheter 8 with an inner catheter lumen 10 (e.g., a through lumen) couldwithstand media pressures 14, tensile and compressive forces, androtational forces as the everting balloon membrane 6 traverses curved ortortuous anatomy, to allow for the passage of an instrument, catheter,media, or materials within the through lumen. Movement of theadvancement button on the handle moves the inner catheter 8 within thethree-way connector 56 and through the outer catheter 4. The evertingballoon 18 can then evert and roll out of the outer catheter 4 andtraverse the target site (e.g., the cervical canal).

After accessing the target site, for example, the user can activate thepressure release control 60 to release or reduce the pressure from themedia volume 12 thereby deflating or reducing the outer diameter of theeverting balloon 18, and/or manually withdraw the everting balloon 18and inner catheter 8 by retracting the advancement slide 48 or pullingthe system handle 30 proximally, and therefore the remainder of thesystem.

Once the biological lumen to be traversed (e.g., the cervical canal, orurethra) is traversed by the everted balloon 18, the everting balloonsystem 2 can increase the pressure in the everting balloon 18, forexample increasing the diameter of the everting balloon 18, or whilemaintaining a constant diameter everting balloon 18 (e.g., for afiber-reinforced everting balloon 18 or a balloon membrane 6 constructedfrom a less distensible material). The pump lever 36 can be compressedto increase pressure in the fluid reservoir 42 builds and exits thedistal pressure check valve 52. The proximal check valve 54 can preventor minimize the fluid media (e.g., pneumatic or hydraulic pressure) fromleaking or bleeding in the proximal direction and out of the inlet port40.

The user can rotate the pump lever 36, for example increasing thepressure in the fluid reservoir 42, the media volume 12, and theeverting balloon 18. The balloon outer diameter can then increase,further pushing open the diameter of the biological lumen. For example,the everting balloon 18 can dilate the cervix and cervical canal. Toolssuch as endoscopes, instruments, Hegars, other devices to increase thediameter of the cervix further, or combinations thereof, can then beinserted into the dilated cervical canal concurrent with the evertingballoon system 2 being located in the cervical canal or subsequent tothe everting balloon system 2 being withdrawn from the cervical canal.

The pump lever 36 can deliver tactile feedback to the user indicatingthe pressure of the everting balloon 18. The everting balloon system 2can have a pressure gauge indicating the pressure in the media volume12, such as in the liquid reservoir 42 and/or the media volume 12 in thecatheters and everting balloon 18.

The system handle 30 can have a pressure release control 60, such as atoggle lever or knob. The pressure release control 60 can release fluidfrom the liquid reservoir 42 and/or media volume 12 of the catheters andeverting balloon 18.

The pressure release control 60 can be connected to the hemostasis valve58. The hemostasis valve 58 can have a seal or sealing gasket. Thepressure release control 60 can be configured to open and close thesealing gasket by rotating the sealing cap, or open a connection to aseparate drainage tube (not shown) in fluid communication with the mediavolume 12.

The pressure release control 60 can be on the handle 30 positioned bythe user's thumb position, distal to and collinear with the movement ofthe advancement slide 48. The pressure release control 60 can beoperated by the same hand as the user is operating the advancement slide48 and pump lever 36.

The user can perform the following operations of the everting balloonsystem 2 with a single hand (e.g., without their other hand or anotheroperator) without a change of hand position:

-   -   a. pressurize the liquid reservoir 42;    -   b. position or place the distal end of the everting balloon        system 2 at the patient's cervix;    -   c. control the everting balloon system 2 position throughout        use;    -   d. advance the inner catheter 8 and balloon membrane 6;    -   e. increase the diameter of the everting balloon 18 by pumping        additional hydraulic pressure from the fluid reservoir 42;    -   f. retract the inner catheter 8 and balloon membrane 6; and    -   g. activate the pressure release control 60 to remove or release        pressure from the everting catheter system.

Structurally, the buttons and actuators to enable these functions can bepositioned on the handle to allow for the operator to manipulate thesefeatures without a change of hand position or requiring the use of theother hand. For instance, advancement and retraction of the innercatheter 8 can be performed by a slide mechanism or gear wheels that arelocated on the upper side of the handle approximately 4 inches from theproximal end of the handle or handle grip. Levers and ratchet mechanismscan be located on the lower or underneath side of the handle at adistance of from about 2 inches to about 4 inches from the proximal endof the handle grip. Additional actuators can be placed on the lateralsides of the handle grip from about 3 inches to about 4 inches from theproximal end of the handle grip or on the upper or lower portions of thehandle grip from about 3 inches to about 4 inches from the proximal end.The button and actuator position can be palpable for the operatorwithout requiring visual confirmation, thereby allowing the user tomaintain eye contact with the patient or visualization source such as anendoscopic monitor or ultrasound image.

During the use of the everting balloon system 2, the user can utilizetheir other hand for handling an ultrasonic probe, a tenaculum (e.g., ifthe cervix is difficult to access by anatomical reasons or is severelyretroverted or anteverted), stabilizing the patient or otherinstruments, or combinations thereof.

FIG. 3A illustrates that the inner catheter 8 can be attached to adilating balloon 62 or inner catheter balloon. The dilating balloon 62can be radially inside of the everting balloon 18. The distal end andthe proximal end of the dilating balloon 62 can be attached and sealedto the inner catheter 8. The inner catheter 8 can have a dilatingballoon port 64 longitudinally within the dilating balloon 62. Thedilating balloon port 64 can be in fluid communication with a fluidpressure source at the proximal end of the everting balloon system 2,for example in or attached to the system handle 30. The dilating balloon62 can be inflated and deflated through the dilating balloon port 64.

The dilating balloon 62 can be more, the same, or less compliant thanthe everting balloon 18. The everting balloon 18 wall can be thicker,thinner, or the same thickness as the dilating balloon 62 wall. Theeverting balloon 18 can be made from one or more polymers includingsilicone, urethane, rubber, latex, polyethylene, polyolefin, irradiatedpolyolefin combined with ethylene vinyl acetate, co-polymers such aspolyether block amide (PEBA, also known as Pebax), a fiber-reinforcedpolymer, PET, nylon, or combinations thereof. The dilating catheter canbe made from any of the materials mentioned for the everting balloon 18.

The everting and/or dilating balloon membrane 6 can have a thicknessfrom about 0.001 in to about 0.004 in.

The everting and/or dilating balloon 18, 62 can be internally coatedwith a lubricious material such as silicone oil, mineral oil, otherlubricant, or combinations thereof. The lubricous coating can reduce thefriction within the balloon during eversion.

The exterior of the everting and/or dilating balloon 18, 62 can besmooth, for example the balloon can be made by tubing extrusion. Theballoons can be blow molded. For example, the exterior surface of theballoon can have ridges or other surface protrusions, for example toincrease friction or holding forces in the target body lumen (e.g.,cervical channel or urethra). The outer diameter of the balloons canvary dimensionally. For instance, the most distal portion of theeverting balloon 18 can be manufactured with a larger outer diameter toaccommodate larger vessel sizes or inflation that can extend into thebladder.

During use, the everting balloon 18 can pull the inner catheter 8 intothe endocervical canal. When the everting balloon 18 is deployed intothe cervical channel, the dilating balloon 62 can be positioned in thecervical channel

FIG. 3B illustrates that the dilating balloon 62 can be inflated bydelivering pressurized fluid through the dilating balloon inflation port64. The dilating balloon 62 can expand inside of the everting balloon18. The dilating balloon 62 can inflate to a dilating balloon diameter66.

The dilating balloon 62 can have a predetermined or molded size andshape. For example, the dilating balloon 62 can have a dilating balloondiameter 66. For example, the maximum dilating balloon diameter 66 ormaximum everting balloon diameter can be from about 2 mm to about 12 30mm, and for some applications, up to about 20 mm in diameter (e.g., foruse in a cervix), and more narrowly from about 2 mm to about 10 mm(e.g., for use in a urethra), more narrowly from about 6 mm to about 12mm, yet more narrowly from about 2 mm to about 7 mm (e.g., for use in aurethra), yet more narrowly from about 3 mm to about 4 mm (e.g., for usein a male urethra). The dilating balloon 62 can inflate to a presetouter diameter. (The dilating balloon outer diameter 66 can be equal toor less than the dilating diameter needed for the body lumen, such asthe cervix.) The everting balloon 18 can have a maximum everting balloondiameter equal to or less than the maximum dilating balloon diameter 66.

The dilating balloon 62 can be inflated to the same or a higher pressurethan the everting balloon 18. For example, the dilating balloon 62 canhave a dilating balloon pressure from about 4 atmospheres to about 12atmospheres of pressure, and up to about 20 atmospheres of pressure, forexample for disrupting a pathological stenosis or condition within abodily lumen.

When the dilating balloon 62 is inflated, the everting balloon 18 canstretch due to the expanding dilating balloon 62 to the dilating balloondiameter 66. The inflation media within the everting balloon 18 canremain inside the balloon or be withdrawn before, during, and/or afterinflation of the dilating balloon 62. Due to the frictional forces ofthe everting balloon membrane 6 on the bodily lumen in the evertedstate, for example, the everting balloon membrane 6 can serve tomaintain the position of the dilating balloon 62 during the dilationprocess without unintentional advancement or retraction of the systemwithin the bodily lumen during the dilatation process.

The dilating balloon 62 can inflate and tear or break the evertingballoon 18 as the everting balloon diameter expands beyond the strainlimit for the everting balloon 18. The inflation media within theeverting balloon 18 can remain inside the balloon or be withdrawnbefore, during, and/or after inflation of the dilating balloon 62, forexample exiting the everting balloon 18 can exit when the evertingballoon 18 tears open.

The everting balloon 18 can break or tear along an intentional line uponthe inflation of the dilating catheter. For example, the evertingballoon 18 can be torn by a mechanical instrument on or within the outercatheter 4, a sharp implement on the proximal portion of the innercatheter 8 that becomes active upon full eversion and inflation of thedilating balloon 62, and/or further advancement of the inner catheter 8that disengages the attachment or bond between the everting balloon 18and the inner catheter 8 on the distal end of the inner catheter 8. Thetearing or splitting of the everting balloon 18 can be done be weakeningthe everting balloon 18 with a mechanical indentation or seam on theballoon membrane 6 that splits upon reaching a specific strain limit,such as along a helical line, lateral line, longitudinal line, orcombinations thereof. The everting balloon membrane 24 can bemanufactured with increased longitudinal axial orientation of themolecular structure by tensioning or expanding the membrane along thelongitudinal axis of the balloon during the balloon forming processwhich can promote a longitudinal break if the everting balloon membrane24 splits or tears. A radial tear in the everting balloon 18 can bepromoted by manufacturing the balloon membrane 6 with greater radialorientation of the molecular structure by radially expanding ortensioning the balloon membrane 6 during the balloon forming process.

The system handle 30 can hold the inflation media to be delivered to andfrom the everting balloon 18 and the dilating balloon 62. The inflationmedia can be in the liquid reservoir 42 (e.g., the fluid bag or asyringe piston). The inflation media can be delivered, for example viavalves, to the dilation balloon after the inflation and eversion of theeverting balloon 18. The system handle 30 can have gear wheels or aratchet configured to advance the inner catheter 8. The outer catheter 4can extend about 25 cm distal to the system handle 30. The system handle30 and actuators can inflate the everting balloon 18 and dilatingballoon 62 from control with one hand.

The dilating balloon 62 can be positioned into and dilate the cervix.

FIGS. 4A through 4C illustrate that the inner catheter 8 can be in afully retracted position inside of the outer catheter 4.

FIG. 4A illustrates that the system handle 30 can have a pump lever 36,such as a ratchet handle 68, a syringe connector 70, and a plunger driveplate 72. The ratchet handle 68 can have a finger grip, trigger, lever,pump mechanism, or combinations thereof. The fluid reservoir can be asyringe 74. The syringe 74 can have a volume from about 5 cc to about 20cc, for example about 5 cc or about 20 cc. An open distal port of thesyringe can be attached to and in fluid communication with the syringeconnector 70. The syringe connector 70 can have the distal pressurevalve 52. The syringe connector 70 can be rotatably attached to thesystem handle case 34. The syringe 74 can have a plunger 76longitudinally translatable with the remainder of the syringe 74. Thesyringe 74 can be filled with any media disclosed herein, such assaline, air, gas, or combinations thereof. The liquid reservoir 42 canhave two separate syringes 74, each attached to and in fluidcommunication with the same or different syringe connectors 70. Forexample, a first syringe can be in fluid communication with the evertingballoon 18, and the second syringe can be in fluid communication withthe dilation balloon 62.

The syringe 74 can be locked to the syringe connector 70.

The outer catheter 4 can have an outer catheter distal tip 78. The outercatheter distal tip 78 can be, for example, an atraumatic tip such as anacorn tip or stop. The outer catheter distal tip 78 can be configured toprevent insertion of the outer catheter 4 too far into the targetbiological lumen (e.g., the endocervix).

The outer catheter distal tip 78 can have an outer catheter distal port80. The outer catheter distal port 80 can be large enough to allow theinner catheter 8 and balloons to pass through.

FIG. 4B illustrates that the syringe connector 70 and syringe 74 canrotate, as shown by the arrow, so the longitudinal axis of the syringe74 can be parallel or collinear with the longitudinal axis of the outercatheter 4. The syringe connector 70 can be angularly fixed with respectto the rest of the system handle 30. The plunger drive plate 72 can berotated and/or translated to contact or almost contact the proximal endof the syringe plunger 76.

FIG. 4C illustrates that the system handle 30 can have a plunger driver82. The plunger driver 82 can have a linear rack or plunger drive screw84, plunger drive collar 86, and plunger drive plate 72. The ratchethandle 68 can be squeezed to rotate the plunger drive screw 84, as shownby arrow 87, or linear rack. The plunger drive screw 84 or linear rackcan be configured to translate the plunger drive collar 86. For example,the plunger drive collar 86 can have internal threads engaging withouter threads of the plunger drive screw 84. The plunger drive collar 86can be translatably fixed to the plunger drive plate 72. The plungerdrive collar 86 and plunger drive plate 72 can translate distally withrespect to the remainder of the syringe 74 when the ratchet handle 68 issqueezed. The plunger drive plate 72 can be in contact with and pressthe plunger 76 in a distal direction as shown by arrow.

The ratchet handle 68 can have a ratchet to prevent reversing thedirection of the plunger driver, for example to prevent proximaltranslation of the plunger 76. A release lever can be rotated ordeployed to release the ratchet mechanism for disengagement of theassembly, withdrawal of the system, or redeployment. The ratchet handle68 can have no ratchet or a two-way ratchet, for example controlling thedirection of the plunger driver 82, for example to allow proximal anddistal translation of the plunger 76. The plunger drive plate 72 can befixed to or touching but unfixed to the plunger 76.

Squeezing the ratchet handle 68 can depress the syringe plunger 94.Depressing the syringe plunger 94 can force inflation media from thesyringe 74 to the media volume 12 of the dilation and/or evertingcatheter 18, for example pressurizing the respective balloons.

FIGS. 5A through 5F illustrates that the system handle 30 can have astop cock and check valve 88 extending from the three-way connector 56.The stop cock and check valve 88 can be in fluid communication with themedia volume 12. The stop cock and check valve 88 can be outside (asshown) or inside of the system handle case 34. The stop cock and checkvalve 88 can be accessed to add media, remove media, or check thepressure of the media in the media volume 12.

The system handle 30 can have one or more syringe detents 90. Thesyringe detents 90 can removably attach to a portion of the syringe 74to prevent or minimize longitudinal translation of the syringe 74 withrespect to the system handle case 34. The syringe detent 90 can beconfigured to allow the syringe 74 to slide in and out of the detenttransverse to the longitudinal axis of the syringe 74.

The system llcasell handle case 34 can have a deflecting plate 92. Theouter and/or inner catheters 4, 8 can press against the deflecting plate92. The deflecting plate 92 can alter or deflect the path of the outerand inner catheters 4, 8 towards the longitudinally axial direction ofthe target site. The deflecting plate 92 can have a molded or formedgroove, pins, plate, panel, or combinations thereof. The outer catheter4 can be manufactured with a preset curve to accommodate the curved pathwithin the system handle case 34.

The system handle case 34 can have a handle grip 96. The inner catheter8 can have a linear inner catheter grip length 98. The inner cathetergrip length 98 can be a length of the inner catheter 8 in the unevertedstate in the handle grip 96. The inner catheter grip length 98 can beabout 12 cm of inner catheter 8 in the uneverted state, for examplecorresponding to an eversion length for the inner catheter grip length98 of about 6 cm (e.g., about 50% of the inner catheter grip length 98)of everted balloon membrane 24. Alternatively, the inner catheter 8 canbe configured to coil up on wheel, have telescoping segments, or havefolding and unfolding segments, to reduce the amount of distance neededwithin a system handle case 34 to accommodate the length of innercatheter 8 in the uneverted state.

The system handle 30 can have a reservoir-catheter channel 100, forexample in fluid communication with the distal end of the syringe 74 andthe proximal end of the inner catheter 8. The reservoir-catheter channel100 can be a tube from the syringe connector 70 to the inner catheter 8.

The system handle 30 can have an access channel 102 extending from anexternal surface of the system handle connector 32 to an externalsurface of the system handle case 34. The access channel 102 canproximally terminate at a proximal access port 104.

The inner catheter 8 can extend through the access channel 102. One ormore tools or fluids can be inserted through, and/or suction can beapplied to, the proximal access port 104 and access channel 102 into andthrough or adjacent to the inner catheter 8.

The system handle 30 can have one or more drive gears 106. The drivegears 106 can be on one or opposite sides of the access channel 102. Thedrive gears 106 can encroach or impinge into the access channel 102. Thedrive gears 106 can be rotatably attached to the system handle case 34via drive gear axles 108. The drive gears 106 can have teethed gearsections and drive gear grooves 124. The inner catheter 8 can extendthrough the drive gear grooves 124. The drive gears 106 can frictionallypush and pull the inner catheter 8. One or more of the drive gears 106can extend and be exposed out of the system handle case 34. For example,the exposed drive gears 106 can be rotated by pressing on the exposeddrive gear 106 with the user's palm or digit (e.g., thumb). The exposeddrive gear 106 can be interdigitally engaged with one or morenon-exposed drive gears 106. Rotating a first one of the drive gears 106can rotate other drive gears 106 interdigitally engaged with the firstdrive gear 106.

The system handle case 34 can have a system handle case first lateralportion 110 and a system handle case second lateral portion 112. Thesystem handle 30 can be made by attaching the system handle case firstlateral portion 110 to the system handle case second lateral portion112. Each drive gear axle 108 can be rotatably attached to the systemhandle case first lateral portion 110 and the system handle case secondlateral portion 112.

The pump lever axle can be a ratchet handle axle 114. The ratchet handle68 can rotate around the ratchet handle axle 114.

The system handle 30 can have a plunger drive rack 116. The plungerdrive rack 116 can be fixed to the plunger drive plate 72. The plungerdrive plate 72 can extend perpendicularly from the proximal end of theplunger drive rack 116. A side of the plunger drive rack 116 facingtoward the plunger drive plate 72 can have unidirectional orbidirectional drive teeth 118.

The system handle 30 can have a ratchet handle spring 120 compressedbetween the system handle case 34, and/or the ratchet handle 68, and/ora ratchet arm 122. The ratchet handle spring 122 can reset the ratchethandle 68, for example by rotating the ratchet handle 68 forward, afterthe ratchet handle 68 has been squeezed.

The system handle 30 can have the ratchet arm 122 or actuating pawl. Theratchet arm 122 can be mechanically attached to the ratchet handle 68,for example to the handle spring 120. The ratchet arm 122 can be in atrack limiting motion of the ratchet arm 122 to translation in thelongitudinal direction with respect to the syringe 74. The proximalterminal end of the ratchet arm 122 can be curved in a u-shape. Theterminal end of the ratchet arm 122 can press against a ratchet tooth.The ratchet arm 122 can be configured to pull the plunger drive rack 116distally when the ratchet handle 68 is squeezed. The ratchet arm 122 isconfigured to move proximally with respect to the plunger drive rack 116when the ratchet handle 68 is returned to a reset position.

The system handle 30 can have a locking pawl (not shown) can bespring-loaded between the system handle case 34 and the plunger driverack 116, for example, allowing distal translation of the plunger driverack 116 and preventing proximal translation of the plunger drive rack116 except when the locking pawl is manually released from the plungerdrive rack 116 by the release lever 126.

The outer catheter 4 can have an outer catheter length 128, as shown inFIG. 5B. The outer catheter length 128 can be from about 4 cm to about35 cm, more narrowly from about 10 cm to about 24 cm, for example about17 cm.

FIGS. 6A through 6D illustrate that the system handle 30 can have aninner catheter drive tray 130 translatably attached to the system handlecase 34. A proximal length of the inner catheter 8 can extend proximallyfrom the system handle case 34. The proximal length of the innercatheter 8 can be in, on, or adjacent to the inner catheter drive tray130.

The syringe 74 can have a syringe loading connector 132, such as a luerconnector, at the terminal distal or proximal end of the syringe 74(e.g., the end further from the system handle case 34). A delivery tube133 or delivery device can be attached to the syringe loading connector132 and pressurized media can be delivered through the syringe loadingconnector 132 into the syringe 74.

The delivery tube 133 or delivery device can be disconnected from thesyringe loading connector 132 before deploying the everting balloon 18,as shown in FIG. 6C. The delivery tube 133 can wrap inside the handlegrip 96 and connect the syringe 74 and its pressurization media to thethree-way connector 56 and the hemostasis valve 58 or inlet port 40 forthe dilation balloon 62.

The proximal terminal end of the inner catheter 8 can be attached to theproximal access port 104. The proximal end of the inner catheter drivetray 130 can have one or more access port detents 134. The access portdetents 134 can attach to the proximal access port 104. The access portdetents 134 can removably attach to a portion of the proximal accessport 104 to prevent or minimize longitudinal translation of the proximalaccess port 104 with respect to the inner catheter drive tray 130. Theaccess port detent 134 can be configured to allow the proximal accessport 104 to slide in and out of the access port detents 134 transverseto the longitudinal axis of the inner catheter drive tray 130.

The inner catheter drive tray 130 can be translated along thelongitudinal axis of the inner catheter drive tray 130 to translate theinner catheter 8 (e.g., advance the inner catheter 8 into the targetsite).

The system handle case 34 can have a fluid connection between thesyringe 74 and the outer catheter 4, as disclosed herein.

The ratchet arm 122 can extend away from the drive rack 116 to form arelease lever 126, as shown in FIG. 6A. One or more other release levers126 can extend from other locations on the system handle 30, as shown inFIGS. 6B and 6D. The release lever 126 can be rotated to disengage theratchet arm 122 from the drive rack 116.

The ratchet handle 68 can have a safety lock hole 136. A safety lockhaving a cable or rod can removably extend through the safety lock hole136, for example to create an interference fit against the system handlecase 34 and prevent rotation of the ratchet handle 68, for examplepreventing unintentional or premature media delivery from the syringe74.

The ratchet handle 68 can be laterally split into a catheter sub-handle138 and a media sub-handle 140. The catheter sub-handle 138 can beconfigured to control the advancement of the inner catheter drive tray130. The media sub-handle 140 can be configured to control the pressureof media delivery from the syringe 74. The catheter sub-handle 138 canbe attached to an inner catheter drive rack. The media sub-handle can beattached to a plunger drive rack.

The ratchet handle 68 can control the syringe 74 for applying mediapressure to the everting balloon 18 and dilating balloon 62, andindependently control the translational movement of the inner catheter8.

FIGS. 7A and 7B illustrate that the inlet port 40 can have a female luerconnector. The system handle connector 32 can have a female luerconnector. The outer catheter distal tip 78 can have a soft rubber orpolymerized acorn tip, for example, to assist in stabilizing theeverting system 2 at the opening of the bodily lumen or preventingunintentional advancement of the outer catheter 4 within the bodilylumen.

The reservoir-catheter channel 100 can extend from the three-wayconnector 56 and out of the system handle case 34. The proximal terminalend of the reservoir-catheter channel 100 can be attached to a femaleluer connector and/or the distal pressure valve 52. The distal pressurevalve 52 and/or female luer connector can be connected to the liquidreservoir 42 (not shown).

FIG. 8A illustrates that the three-way connector 56 can have ahemostasis valve 58. The three-way connector 56 can have or be aTouhy-Borst Y-connector. The inner catheter 8 can extend through thethree-way connector 56.

The three-way connector 56 can have a distal gasket 142 between thereservoir-catheter channel 100 and the system handle connector 32. Thedistal gasket 142 can have a cylindrical distal gasket port 144extending through the radial middle of the distal gasket 142. The distalgasket port 144 can have a distal gasket port diameter.

The three-way connector 56 can have a proximal gasket 146 proximal tothe distal gasket 142. The proximal gasket 146 can be between thereservoir-catheter channel 100 and the proximal outlet through which theinner catheter 8 proximally exits the three-way connector 56. Theproximal gasket 146 can be more, the same, or less compliant than thedistal gasket 142. The proximal gasket 146 can have a cylindricalproximal gasket port 148 extending through the radial middle of theproximal gasket 146. The proximal gasket 146 can have a proximal gasketport diameter.

The inner catheter 8 can have an inner catheter small diameter length150 and an inner catheter large diameter length 152 proximal to theinner catheter small diameter length 150. The inner catheter 8 can havean inner catheter proximal inflation hole 154 at the distal end of theinner catheter large diameter length 152. The inner catheter proximalinflation hole 154 can be in fluid communication with the open distalend of the inner catheter lumen 10 and/or the dilating balloon port 64.

Positive media pressure 14 or flow can be delivered, as shown by arrows,through the reservoir catheter channel 100 to the three-way connector56. The inner catheter large diameter length 152 can occlude, plug,and/or seal the proximal gasket port 148. The positive media pressure 14or flow can be delivered through the gap between the outer diameter ofthe inner catheter 8 (e.g., along the inner catheter small diameterlength 150) and the inner diameter of the distal gasket port 144 and tothe media volume 12 between the outer catheter 4 and the inner catheter8, for example to the everting balloon 18.

FIG. 8B illustrates that the inner catheter 8 can be translateddistally, as shown by arrow, at least until the inner catheter largediameter length 152 moves into the distal gasket port 144. The innercatheter large diameter length 152 can slide through the proximal gasketport 148. The inner catheter large diameter length 152 can occlude,plug, and/or seal the distal gasket port 144 and/or against the distalgasket 142. The media 155 flow from the reservoir-catheter channel 100can be forced to flow into the inner catheter proximal inflation hole154. The media 155 can flow down the inner catheter lumen 10, forexample to the dilating balloon 62.

An exemplary procedure for dilating the a body lumen such as thecervical canal can include:

-   -   1. The syringe 74 can be loaded onto the system handle 30. The        system handle 30 can be a separate, reusable item in which the        everting catheter and syringe filled with media 155 can be        attached to the remainder of the system before use.        Alternatively, the system handle 30 can come supplied to the end        user preassembled with the remainder of the system and        pre-filled, or combinations thereof.    -   2. The distal end of the everting balloon system 2 can be placed        at the exocervix.    -   3. The ratchet handle 68 can be depressed. The first one to two        clicks of the ratchet (i.e., as the locking pawl passes over        ratchet teeth) can depress the syringe plunger 94 and pressurize        the everting balloon 18. The everting balloon 18 can be        pressurized to 4 to 6 atmospheres.    -   4. The ratchet handle 68 can be depressed further (or released        to rotationally reset and then depressed further). The next sets        of clicks on the ratchet handle 68 can indicate advancement the        inner catheter 8. This can be accomplished by the ratchet        mechanism rotating gear wheels on the inner catheter 8 and/or        translating a linear rack to advance the inner catheter 8.    -   5. The ratchet handle can be depressed further (or released to        rotationally reset and then depressed further). The advancement        of the inner catheter 8 can continue until the everting balloon        is fully deployed and everted. The dilation balloon 62 can be        positioned on the distal end of the inner catheter 8.    -   6. The ratchet handle 68 can be depressed further. The next        click of the ratchet can de-pressurize the everting balloon 18.    -   7. The ratchet handle 68 can be depressed further. The next        click of the ratchet can change the pressurization outlet of the        syringe 74 from the everting balloon 18 to the dilation balloon        62. This can be accomplished, for example, by:        -   a. rotating a valve with the ratchet mechanism,        -   b. manually rotating the valve, and/or        -   c. advancing the inner catheter 8 to where the inner            catheter proximal inflation hole 154 or port is exposed to            the inflation media, such as shown in FIGS. 8A and 8B.    -   8. The ratchet handle 68 can be depressed further. The next sets        of clicks on the ratchet can indicate the inflation of the        dilatation balloon 62.    -   9. The dilatation balloon 62 may rupture the overlying everting        balloon 18.    -   10. The amount of force in the biological lumen dilatation can        be governed by a pressure relief valve or by the amount of        volume of media 155 that can be placed within the dilatation        balloon 62. The dilatation pressure can be monitored by a        pressure gauge in or attached to the system handle case 34. The        dilation balloon 62 can dilate the cervix with from about 6        atmospheres to about 20 atmospheres. The dilation balloon 62 can        initially deliver about 10 atmospheres to about 12 atmospheres        with a reduction in pressure as the cervix dilates and the        dilatation process is completed. The system can deliver a known        volume of media 155 into the dilation balloon 62 irrespective of        quantifying or measuring the media pressure 14.    -   11. The dilatation process may be observed by ultrasound or        radiographic imaging.    -   12. A pressure relief button on the system handle 30 can be        activated to remove or reduce dilatation pressure in the media        volume 12 in the inner catheter lumen 10.    -   13. The syringe plunger 94 may be retracted to draw vacuum from        the inner catheter lumen 10 and dilation balloon 62, for example        loosening the dilation balloon 62 from the cervix, and/or        deflating the dilation balloon 62, for example to facilitate        removal of the everting balloon system 2 from the cervix.    -   14. The everting balloon system 2 can be re-pressurized, for        example if additional dilatation force is desired in the cervix.        For instance, if an additional stenosis in the cervix is        visible, the dilatation balloon 62 can be repositioned and        inflated in the additional stenosis area.

The everting catheter system can access a bodily cavity (e.g., theuterine cavity or fallopian tubes) to deliver or introduce of tools(e.g., instruments), reproductive (e.g., embryos, in vitro fertilization(IVF) or insemination products, such as hormones) media 155 or material,contrast media, dye, therapeutic agents, sclerosing agents to treat theendometrium, insufflation media, or combinations thereof to the cavity.For example, reproductive media can be delivered with a transfercatheter inserted through the inner catheter lumen 10 to the uterinecavity.

FIG. 9 illustrates that a transfer catheter 156 or insemination cathetercan have a transfer connector 158, such as a female luer connector, astrain relief length 160, and a transfer tube 162. The transfer tube 162can hold the reproductive media. The transfer tube 162 can have aproximal length having a proximal length diameter larger than a distallength diameter of a distal length of the transfer tube 162. A deliveryforce, for example a positive fluid pressure, can be delivered throughthe transfer connector 158 and strain relief length 160 to push thecontents of the transfer tube 162 into the target site.

The transfer catheter 156 can attach to or inserted through the inletport 40. The transfer tube 162 can hold an embryo, for example for invitro fertilization or IVF. The embryo transfer catheter 156 can deliverembryos through the system and to the uterine cavity. The transfercatheter 156 can hold spermatozoa and through the system and to theuterine cavity for intrauterine insemination procedures. The transfercatheter 156 can hold and deliver other materials the deposition ofdrugs, therapeutic agents, instruments, endoscopes, cytology brushes,other catheters, or combinations thereof through the system and into theuterine cavity. The transfer catheter 156 can be connected to a vacuumsource for the aspiration of materials from the uterine cavity or otherbodily cavities and lumens.

The transfer catheter 156 and/or materials can be loaded in the innercatheter lumen 10 prior to everting the everting balloon 18 within thevessel or bodily cavity. For example in the case of delivery ofreproductive material in the uterine cavity, the transfer catheter 156can be loaded with washed and prepared semen in the transfer tube 162and the transfer catheter 156 can be placed in the inner catheter lumen10.

A guidewire can be inserted through the transfer catheter 156 and/or theremainder of the system, for example to direct the tube or system to thetarget site 164. The guidewire can be used for recanalization.

The inner catheter 8 can be extended and the everting balloon 18 canevert and unroll through the cervix and into the uterine cavity.Concurrently or subsequently, the transfer catheter 156 can be advancedthrough the inner catheter lumen 10 into the uterine cavity. Once fullyeverted or when the transfer catheter 156 becomes extended or exposedfrom the inner catheter 8 and beyond the everting balloon membrane 24,the reproductive material 166 in the transfer catheter 156 can bedeposited by a syringe 74, squeeze bulb, piston, or other pressuresystem. A second delivery catheter, such as a second insemination, IVF,or drug delivery catheter can be concurrently inserted into the inletport 40 or a second inlet port. The second delivery catheter can bedeployed to the target site 164 concurrent with or subsequent to thetransfer catheter 156.

The system handle 30 can have a lead-in area. The lead-in area can, forexample, be without steps, edges, bumps, or restrictions that may impedeor contact the distal opening of the transfer catheter 156 duringpassage, for example so that in the case of delivery of inseminationmaterial, the transfer catheter 156 can be easily loaded into the systemhandle 30. An insemination syringe 74 or pump can be attached to theproximal transfer connector to deliver pressure to the transfer tube162, for example to expel the reproductive material 166 once the distalport of the transfer catheter 156 is positioned at the target site 164(e.g., after the everting balloon 18 is fully deployed). The actuationof the insemination syringe or pump on a pre-loaded transfer catheter156 can be performed by the same hand that holds and operates thecomponents of the everting catheter system.

In addition, the transfer catheter 156 can be configured to beintroduced into the proximal connector in the handle of the evertingcatheter system once the system is fully deployed.

The user can perform any or all of the following while using theeverting balloon system 2, for example with a single hand:

-   -   a. pressurize the everting catheter system;    -   b. position the everting balloon system 2 at the patient's        cervix;    -   c. maintain the everting balloon system 2 position throughout        the procedure;    -   d. advance the inner catheter 8 and everting balloon 18;    -   e. once extended beyond the everting balloon membrane 24 or        inner catheter 8, present the transfer catheter 156 for        deposition into the bodily cavity such as a uterine cavity    -   f. retract the inner catheter 8 and everting balloon 18; and/or    -   g. activate (e.g., toggle) the pressure release lever to remove        or release hydraulic or pneumatic pressure from the media volume        12.

FIGS. 10A through 10C illustrate that the distal end of the evertingballoon can form a balloon check valve 168. The length of the evertingballoon 18 distal to the distal terminal end of the inner catheter 8 canradially contract to form a tight orifice that can be the balloon checkvalve 168. The balloon check valve 168 can be an openable barrier thatcan block or interrupt fluid communication between the inner catheterlumen 10 and the target site 164.

The balloon membrane 6 can balloon membrane have from about 1 mm toabout 3 mm of overlapping wall at the balloon check valve 168 closingoff the inner catheter lumen 10. The strength or closing pressure of theballoon check valve 168 can be modulated during use. For example thedistance of overlap of balloon membrane 6 can be increased or decreasedby controlling the amount of excursion available for the inner catheter8 and everting balloon membrane 24.

FIG. 10B illustrates that the distal end of the transfer catheter 156can be advanced, as shown by arrow 170, through the inner catheter lumen10, through the balloon check valve 168, and to the target site 164. Thetransfer catheter 156 can penetrate or push open the balloon check valve168 when the transfer catheter 156 moves through the balloon check valve168. When the terminal distal end of the transfer catheter 156 is distalof the balloon check valve 168 and at the target site 164, thereproductive material 166 loaded in the transfer catheter 156 can bedelivered 172 through a distal port of the transfer catheter 156 andinto the target site 164, such as the uterine cavity.

FIG. 10C illustrates that the transfer catheter 156 can be retractedthrough the balloon check valve 168 and the inner catheter lumen 10after the reproductive material is deposited at the target site 164. Theballoon check valve 168 can close as the transfer catheter 156 isretracted through the balloon check valve 168. The balloon check valve168 can maintain a seal between the inner catheter lumen 10 and thetarget site 164 when the transfer catheter advances 170 through, remainsstationary within, and is retracted through the balloon check valve 168.

The reproductive material 166 can be isolated from vacuum effect or theretraction of reproductive material 166 from the target site 164 as aresult of the vacuum forces created by the withdrawal of the transfercatheter 156 through the system once the deposition of reproductivematerial 166 is completed. The balloon check valve 168 can reduce oreliminate vacuum effect for embryo transfer.

The balloon check valve 166 can be a tactile indicator for the physicianwhen passing the transfer catheter 156 through the everting balloonsystem 2. In transfer procedures, depending upon physician preference orpatient anatomy, for example, the amount of insertion of the transfercatheter 156 through the distal end of the everting system can vary frompatient to patient. As the distal end of the transfer catheter 156passes through the balloon check valve 168, the resistance created bythe balloon check valve 168 can be felt by the physician on the proximalend of the transfer catheter 156. Depending upon the length of balloonchosen to act as a balloon check valve 168, the degree or amount ofresistance can be modulated. In some procedural settings there may be acompromised ability to see the amount of insertion of the transfercatheter 156 into the everting balloon 18, or physical depth indicia ormarkings on the proximal end of the transfer catheter 156. Thecompromised ability to see may be due to low light within the procedureroom so that imaging and visualization of monitors can be enhanced. Inaddition, the physical relationship of the physician, embryologist, orother persons or equipment in the procedure room may compromise theability to see easily the amount of insertion into the evertingcatheter. The tactile sensation of the resistance of the balloon checkvalve 168 can create a palpable indicator that the transfer catheter 156is at the distal end of the everting balloon 18.

The everting balloon system 2 can be used to access and seal the uterinecavity, for example, for the deposition of reproductive material 172 forlong duration intrauterine insemination.

FIGS. 11A through 11C illustrate that the everting balloon membrane 24can create a seal within the cervical canal (e.g., against the cervicalcanal walls 174) as the everting balloon 18 traverses the cervicalcanal. FIG. 11A illustrates that the everting balloon membrane 24 canunroll and advance along the cervical walls, as shown by arrows, as theballoon is pressurized and the inner catheter 8 is distally advanced.The outer catheter 4 can also seal against the cervical canal wall 174.For example, the outer catheter 4 outer diameter can be equal to theeverting balloon outer diameter.

FIG. 11B illustrates that the transfer catheter 156 can advance distallywithin the everting balloon 18 and the inner catheter lumen 10. Thetransfer catheter 156 can deposit the reproductive material 166 (e.g.,sperm) within the uterine cavity 176.

FIG. 11C illustrates that the transfer catheter 156 and/or the innercatheter 8 can be retracted (e.g., from about 3 mm to about 10 mm) orinverted, as shown by arrows, to close the distal end of the innercatheter lumen 10, as shown by arrows, with respect to the uterinecavity 176. The distal opening of the balloon 178 can close, for exampledue to the pressure within the everting balloon 18 forcing the evertingballoon 18 to form the balloon check valve 168. The balloon check valve168 can seal the cervical canal and the uterine cavity 176 from theinner catheter lumen 10. The reproductive materials 166 can remain inthe uterine cavity 176 without being expelled through the cervix.

FIG. 12 illustrates that the outer catheter 4 and inner catheter 8 canbe configured to be de-coupled from the everting balloon membrane 24 anda distal closure tip 180. The distal closure tip 180 can be configuredto connect to and seal off the everting balloon 18.

After delivery of the reproductive materials 166 to the uterine cavity176 (i.e., insemination) is complete, the outer and inner catheters 4, 8can be decoupled from the everting balloon 18 and the distal closure tip180. After the catheters are removed from the everting balloon 18, theeverting balloon 18 can remain inflated or pressurized. A one-wayballoon closure check valve that can remain within the distal closuretip 180 when the catheters are removed. The one-way balloon closurecheck valve can be connected to the balloon membrane 6 with a conduitwithin the distal closure tip 180 and can seal the everting balloon 18.A one-way check valve such as a duck bill valve within the distalclosure tip 180 can keep the reproductive material 166 in the uterinecavity.

After the outer catheter 4 and inner catheter 6 are de-coupled from theballoon 178 and removed from the cervix, the distal closure tip 180 canremain in the cervical canal and/or the vagina. The distal closure tip180 can be made from biocompatible materials and a low durometer, softand conformable silicone. The everting balloon 18 can remain pressurizedand sealing the cervical canal.

The distal closure tip 180 can have a plug 182 sealing the balloon 178and a pull string 184 attached to the plug 182. (The pull string 184 canbe made from materials known for use for strings used commonly intampons.) After a desired duration of time of keeping the cervical canalsealed without allowing the reproductive material 166 (e.g., sperm) toexit the uterine cavity 176, and reproductive tract of the female,through the cervix, the everting balloon 18 can be deflated and/orremoved by pulling on the pull string 184 to remove the plug 182, orpulling directly on the plug 182. The pull string 184 can be connectedto the plug 182. The plug 182 can be connected to a proximal port of apressurization release channel 186 in fluid communication with theeverting balloon 18. For example, the pull string 184 is connected tothe plug 182 and the length string can continue further by beingconnected to the distal closure tip 180. Before, during, or after theeverting balloon 18 is deflated, the remaining elements can be removedfrom the cervix. The distal closure tip 180 may or may not be removeduntil after the everting balloon membrane 24 is deflated.

The pull string 184 can be pulled by the physician or healthcareprofessional or alternatively, by the patient at home. The patient canbe ambulatory while the everting balloon 18 remains in the cervicalcanal. While sealed, the reproductive material 166 can be containedwithin the uterine cavity 176 without being expelled through the cervixby gravity, contractions, or movements by the patient.

The distal closure tip 180 can have a pressurization release channel 186in fluid communication with the everting balloon 18 and a pressurizationrelease check valve 188. The pressurization release check valve 188 canbe a one-way check valve. The pressurization release check valve 188 canbe opened to depressurize and deflate the everting balloon 18. Thedeflated balloon 178 can then be removed from the cervical channel bythe patient or physician. For instance, the pressurization release checkvalve 188 can have a duck bill valve that can allow air and fluid totravel into the distal tip and pressurize the everting balloon membrane24. The everting balloon 18 can be inflated or the internal pressure canbe increased through the pressurization release check valve 188.

The pressurization release check valve 188 can be attached to a pullstring 184. For example, the pull string 184 can be attached to the bodyof the duck bill valve. The user can pull the pull string 184, removingthe duck bill valve from the distal closure tip 180, deflating theeverting balloon 18, and then removing the distal closure tip 180 andeverting balloon 18.

FIGS. 12A, B, and C illustrate that the system can have an innercatheter plunger 190 in the outer catheter. The proximal terminal end ofthe inner catheter plunger 190 can have a plunger proximal connector192. The plunger proximal connector 192 can have a port or hole, forexample configured to connect to a fluid delivery device to fill theeverting balloon 18 and/or plunger 76 housing with pressurized media 155(e.g., saline, air). The everting balloon 18 can also be pre-filled withmedia 155 and fluidly sealed.

The inner catheter plunger 190 can have a plunger first body 194 and aplunger second body 196. The distal closure tip 180 can have a plungero-ring 198 configured to form a seal around the inner catheter plunger190 where the inner catheter plunger 190 enters the distal closure tip180. The terminal proximal end of the inner catheter 8 can be attachedto inner catheter stop 200. The inner catheter stop 200 can have asealing gasket (e.g., the plunger o-ring 198 and/or a different sealingelement) exterior to and concentric with the inner catheter 8.

The diameter of the inner catheter plunger 190 can decrease at adiscreet slope along the length of the inner catheter plunger 190. Theradially outer side of the distal end of the inner catheter plunger 190can have one or more mechanical decoupling detents 202, for example, onthe discreet slope. The decoupling detents 202 can extend radiallybeyond the radially outer surface of the remainder of the distal end ofthe inner catheter plunger 190.

The terminal proximal end of the distal closure tip 180 can have one ormore coupling connectors 204. The coupling connectors 204 can have oneor more flanges configured to releasably attach to the distal terminalend of the outer catheter 4.

The inner catheter plunger 190 can be configured to distally advance theinner catheter 8. The inner catheter plunger 190 can press against theinner catheter stop 200, translating and everting the inner catheter 8.After being fully distally advanced to a fully everted position, theinner catheter 8 can be exposed to the target site 164 and ready for thedelivery of reproductive material 166 to the target site 164. Afterdelivery of the reproductive material 166 to the target site 164, theinner catheter 8 can be retracted, for example by retracting the innercatheter plunger 190, until a mechanical stop is reached and the plunger76, plunger proximal connector 192, and outer catheter 4 becomedisconnected from the inner catheter 8 which remains within the distalclosure tip 180. The sealing gasket can be on the exterior circumferenceof the inner catheter 8, for example, to prevent leaking of, and keeppressurization of the everting balloon 18 pressurized. The outercatheter 4, containing the proximal connector 206 and plunger 76, can bedisconnected from a coupling with the distal closure tip 180 by a numberof possible manipulations including twisting, pulling, or pressing anactuator, or combinations thereof. The decoupling can be automatic whenthe distal end of the proximal connector 206 mechanically engages andexpands the flanges to release the coupling on the outer catheter 4.

FIGS. 12B illustrates that the inner catheter plunger can be in anattached configuration, not exerting radially outward pressure on theouter catheter.

FIG. 12C illustrates that the proximal ends of the plunger first body194 and plunger second body 196 can be rotated toward each other, asshown by arrows, causing a radially outward rotation of the distal endsof the plunger first 194 and second bodies 196. The detents can pressthe outer catheter 4 radially outward. The radial expansion of the outercatheter 4 can expand the distal terminal end of the outer catheter 4.The outer catheter 4 can then disengage from the coupling connector 204and the distal closure tip 180. The subsequent withdrawal of the outercatheter 4 can remove the distal end of the proximal connector 206 fromthe inner catheter 8. The inner catheter 8 can remain in the distalclosure tip 180.

After full deployment of the everting balloon membrane 24 and depositionof reproductive material 166, the motion of the proximal connector 206in the proximal or retraction (e.g., reverse) direction to create aone-way balloon check valve can mechanically disengage the couplingconnector 204 (e.g., flanges) by use of ramps, detents, bumps, or stepsthat mechanically act on the flange, or the outer catheter housingitself, to then decouple the outer catheter 4, proximal connector 206and plunger 76 from the distal closure tip 180.

The everting balloon 18 can be pressurized through the pressurizationrelease check valve 188 within the distal closure tip 180 and maintainedby a plug 182 with pull string 184 attached. For example, the plug 182can be inserted into the pressurization release check valve 188. Any ofthe liquid reservoirs 42 and respective pressurization systems can beused, such as a syringe 74, inflation device, and/or air or fluid pump.

The pressurization release check valve 188 and the plug 182 can bewithin the same component. For example, a releasable one-way valve suchas a duckbill valve can be attached to a pull string 184. Thepressurization release check valve 188 and/or plug 182 can be dislodgedfrom the respective sealing areas, for example, providing reinflationfor the everting balloon 18.

The everting balloon system 2 can seal the cervical canal, for example,as follows:

-   -   a. The everting balloon 18 can be pressurized by an inflation        device or air/liquid pump before placing the device adjacent to        a cervix.    -   b. The distal end of the everting balloon system 2 can be placed        at the patient's cervix.    -   c. The position of the everting balloon system 2 can be        maintained throughout the procedure (e.g., the device can        operate via one-handed operation).    -   d. The inner catheter 8 and everting balloon membrane 24 can be        distally advanced through the cervical canal.    -   e. The transfer catheter 156 can advanced distally through and        beyond the everting balloon 18 or inner catheter 8.    -   f. The transfer catheter 156 can deliver reproductive material        166 into the uterine cavity 176 or use a syringe 74 to deposit        the reproductive material 166 through the proximal connector 206    -   g. The inner catheter 8 and everting balloon 18 can then be        proximally retracted with respect to the target site 164.    -   h. The outer catheter 4 and inner catheter 8 can then be        detached or decoupled from the distal closure tip 180 and        removed proximally from the distal closure tip 180. For example,        the inflated distal tip can be left in the cervix and the        everting balloon 18 can remain pressurized.    -   i. Part or all of the everting balloon system 2 can be left        within the body for a pre-determined duration of time    -   j. The pull string 184 can be pulled to remove the plug 182        and/or pressurization release check valves 188. The pull string        184 can be connected to the plug 182 to remove hydraulic        pressure from the everting catheter system. The everting balloon        18 can deflate.    -   k. The pull string 184 can be attached to the everting balloon        18 and/or distal closure tip 180 and pulled to withdraw the        deflated everting balloon 18 and/or distal closure tip 180 from        the body.

The everting balloon system 2 can be inserted into and occlude theurethra, for example to treat urinary incontinence in the male orfemale. The everting balloon 18 can act as a urethral insert.

The everting balloon system 2 can create a seal in a urethral channel orpassage. Once positioned into or at the urethral opening, the user canpress the surface of the outer catheter distal tip 78 or evertingballoon base against the urethral opening. The user can then activatesthe pressurization source and extrudes the everting balloon 18. Theeverting balloon system 2 can self-propel along the urethral channel.The balloon material occupies the inner lumen 8 of the urethra as iteverts and thereby creates a sealing element. The everting balloonmembrane 2 can be filled with saline, air, or a combination of both.

The everting balloon 18 can lock into place within the urethra. Theeverting balloon 18 can deliver radial forces to the inner lumen 8 ofthe urethra.

The everting balloon system 2 can be compact and designed forself-insertion and removal by the patient. Bladder voiding can occurafter removal of all or part of the system from the urethral passage orafter a sealing mechanism in the system is inactivated or removed.

FIG. 13A illustrates that the everting balloon system 2 can have anouter catheter 4 that is a syringe housing 208. A plunger 76 within thesyringe housing 208 can be distally detachably connected to a mediavolume cap 210. The plunger 76 can be proximally retracted, for examplebeing ready for advancement. Part or all of the syringe housing 208,such as the portion within the everting balloon 18, can be filled withinflation media such as described herein. The syringe housing 208 and/orplunger 76 can be a reusable component of the everting balloon system 2that is attached to the remainder of the everting balloon system 2before deployment of the everting balloon 18 by the user.

Cap lock pegs 212, collars, grooves, or a luer fitting can extenddistally from or proximally into the radially outer portions of thedistal and/or radial sides of the media volume cap 210.

The radially inner terminal end of the everting balloon membrane 24 canbe attached to the radially central portion of the cap lock. The caplock can form a fluid-tight seal against the radial inside of thesyringe housing 208.

The outer catheter distal tip 78 can have a distal tip membraneinterface 214. The distal tip membrane interface 214 can have teeth ortexturing (e.g., knurling, ridges, bumps) extending radially outwardly.The radially outer end of the balloon membrane 6 can attach to thedistal tip membrane interface 214. The outer catheter distal tip 78 canhave an everting balloon membrane collar 216. The everting membranecollar 216 can have teeth or texturing (e.g., knurling, ridges, bumps)extending radially inwardly. The radially outer end of the balloonmembrane 6 can be squeezed between the everting membrane collar 216 andthe distal tip membrane interface 214 to attach to the outer catheterdistal tip 78.

The outer catheter distal tip 78 can have a flange radially extendingfrom the remainder of the outer catheter distal tip 78. The user canidentify the urethral opening. The outer catheter distal tip 78 can bepositioned at the urethra opening and then translated and inserted intothe urethra 218. As the outer catheter distal tip 78 is translated intothe urethra 218, the urethra 218 can abut the flange, for example tostop translation of the outer catheter distal tip 78 with respect to theurethra 218. The flange can be outside of the urethra 218 in the maleand outside the urethra 218 in the vagina in the female. The outercatheter distal tip 78 can be made from a low durometer, soft andconformable biocompatible material such as silicone.

The distal end of the syringe housing 208 can detachably connect to theproximal end of the outer catheter distal tip 78 at a fluid-tight tipconnector. For example, the distal end of the syringe housing 208 candetachably connect to the proximal end of the outer catheter distal tip78 at a circumferential snap connector or luer connector.

Cap lock ports 220, collars, grooves, or a luer fitting can extenddistally from or proximally into the radially outer portions of thedistal and/or radial sides of the media volume cap 210.

The outer catheter distal tip 78 can act as the distal closure tip 180.

The syringe housing 208 can be used as a handle to manipulate theposition and orientation of the system.

FIG. 13B illustrates that the plunger 76 can be depressed or translated,as shown by arrow 222, toward the outer catheter distal tip 78, forexample translating the media volume cap 210 to press into the proximalend of the outer catheter distal tip 78.

The radially inner end of the balloon membrane 6 and the inflation mediain the media volume 12 can be pressed distally, for example, causing theeverting balloon 18 to propel, unroll and evert, as shown by arrows 221,into the urethra 218. The cap lock peg 212 can engage and attach the caplock port 220. The cap lock peg 212 attached to the cap lock port 220can form a fluid-tight seal. When the cap lock peg 212 attached to thecap lock port 220, a palpable disengagement of the syringe housing 208can be felt by the user. The plunger 76 and syringe housing 208 can havethumb and finger rings, for example to separately control the plunger 76and the syringe housing 208 with a single hand.

The syringe housing 208 can be disengaged and detached from theinflation check valve and/or outer catheter distal tip 78 at the tipconnector 224 and removed. The syringe housing 208 can disengage fromthe outer catheter distal tip 78 concurrently or subsequently to the caplock peg 212 attaching to the cap lock port 220.

The proximal end of the outer catheter distal tip 78 and/or the distalend of the syringe 74 can have a one-way inflation check valve, forexample preventing or minimizing backflow of media 155 into the syringe74. The everting balloon 18 can distend the urethra 218, as shown byarrows 228, and create a fluid-tight seal against the wall of theurethra 218. The everting balloon 18 can automatically traverse theurethra 218, for example, without delivering a shear force to theurethra wall. The everted balloon 18 can extend to the proximal terminalend of the urethra 218, into the bladder 226, or stop short of theproximal terminal end of the urethra 218.

Distal force can be delivered to the syringe housing 208, plunger 76, orouter catheter distal tip 78, for example to prevent dislodgement of theeverting balloon 18 during eversion, such as at the beginning ofeversion before the everting balloon 18 fixes to the urethra 218.

The everting balloon 18 can be pressurized and can plug and seal thepassageway of the urethra 218.

The everting balloon 18 can seal throughout the urethral passageway bycreating radial pressure throughout the urethra 218. Since the mechanismof action of the everting balloon 18 is independent of urethral length,a sizing procedure is not needed. Avoiding multiple sizes simplifiesphysician fitting and does not require greater inventory.

The everting balloon 18 can be soft and conformably anchored, forexample, since the everting balloon 18 fills space and thus exertedpressure evenly along the length of the everting balloon 18 in theurethra 218. As the patient moves, bends, coughs, or provides pressureon the pelvic floor, the everting balloon 18 can conform to the shape ofthe urethra 218, maintaining a seal until removed or deflated, forexample by the patient.

The system can include an everting balloon 18 that everts and expandsimmediately upon pressurization. This can be accomplished by having themost distal portion of the outer catheter distal tip 78 constructed withexposed everting balloon membrane 24. In use, the most distal portion ofthe outer catheter distal tip 78 can intubate the urethra 218 with theexposed portion of the everting balloon membrane 24 contacting the inneros of the urethra 218 for a distance of 1 to 5 mm Thus atpressurization, the everting balloon membrane 24 can begin to lock intoplace and thereby reduce backing out. The remainder of the evertingballoon 18 can be maintained within the case unit up until thepressurization process is initiated. In this fashion, the invasiveportion of the everting balloon 18 that enters the urethra 218 can beprotected from contact from the user hands and other areas that cancontaminate the balloon 178.

The everting balloon membrane 24 can be housed completely within thedistal outer catheter tip 78 with the most distal portion of the distalouter catheter tip 78 can be distensible and expand immediately uponpressurization of the everting balloon membrane 24. The distensibleportion of the distal outer catheter tip 78 can radially expand andcontact the inner wall of urethra 218 to provide locking forces.

A cylindrical open-ended tube can be used as an inserter to protectinadvertent contact of the everting balloon 18 from vaginal side walls,for example, to prevent contamination of the everting balloon 18 withvaginal flora or detritus during the insertion process.

FIG. 13C illustrates that the everting balloon 18 can be deflated afterinsertion and deployment into the urethra 218. The everting balloon 18can be removed from the urethra 218 and/or deflated, for example forbladder voiding (i.e., urinating). One or both of the flanges 230 can bepinched or compressed toward each other by the user to deform the outercatheter distal tip 78 and open the pressurization release check valve188 in the outer catheter distal tip 78. The inflation media 231 canthen exit the pressurization release check valve 188, deflating theeverting balloon 18. The everting balloon 18 and outer catheter distaltip 78 can then be pulled out of the urethra 218 and removed from thepatient.

The outer catheter distal tip 78 can have a pull string 184 attached tothe proximal end of the remainder of the outer catheter distal tip 78.The pull string 184 can be pulled to remove the everting balloon 18 andouter catheter distal tip 78 (e.g., in the same fashion as the removalof a tampon).

FIGS. 14A, 15A and 15B illustrate that the outer catheter distal tip 78can have a pressurization release check valve 188 through which themedia 155 can enter to pressurize and inflate the everting balloon 18.The pressurization release check valve 188 can be a one-way valvepreventing or minimizing media 155 flow out of the everting balloon 18to the surrounding environment. For example, the pressurization releasecheck valve 188 can have a duck bill or micro valve. The plug 182 andexternal port of the respective pressurization release channel 186 canbe located radially central on the proximal side of the outer catheterdistal tip 78.

FIGS. 14B and 15C illustrate that the pull string 184 can be fixed tothe body of the outer catheter distal port 80. The plug 182 can beattached to the pull string 184. For example, the pull string 184 canextend through the plug 182. For example, the plug 182 can be glued to,welded to, clipped to, or over-molded onto the pull string 184. The pullstring 184 can be pulled to remove the plug 182 from the external portof the pressurization release channel 186, and the media 155 from theeverting balloon 18 can then be released to the surrounding environment.The everting balloon 18 can then depressurize and deflate. The pullstring 184 can be pulled, removing the outer catheter distal tip 78 andeverting balloon from the urethra 218.

Once the positive lock mechanism is defeated by the pulled string 184,the everting balloon 18 is deflated and the entire device can be removedand disposed.

FIGS. 14A and 14B illustrate that the distal terminal end of the outercatheter distal tip 78 can have a distally protruding, pointed, acorn,nipple, or conical shape configuration.

FIGS. 15A through 15C illustrate that the distal terminal end of theouter catheter distal tip 78 can have a smooth, rounded, concave shapethat can minimize intubation into the urethra 218.

FIGS. 16A and 16B illustrate that the outer catheter distal tip 78 canhave a tip distal extension 232. The tip distal extension 232 can extenddistally from the remainder of the outer catheter distal tip 78. The tipdistal extension 232 can have a tip distal extension length 234. The tipdistal extension length 234 can be from about 1 mm to about 4 mm The tipdistal extension 232 can be cylindrical. The tip distal extension 232can be inserted into the body lumen, such as the urethra 218, before theeverting balloon 18 is everted.

FIG. 17 illustrates that the inflation device can be a syringe 74. Thesyringe 74 can be connected to the pressurization release check valve188. The plunger 76 can be depressed into the syringe 74, deliveringmedia 155 under pressure through the pressurization release check valve188 and into the everting balloon 18, for example, to inflate, expand,advance, propel, and evert the everting balloon 18.

FIGS. 18A and 18B illustrate that the inflation device can be a smallmotorized air (or other gas or liquid) pump 236. The pump 236 can have apump power switch 238 to control the pressure delivery from the pump236. The pump power switch 238 can be a push button or toggle. The pumppower switch 238 can control the flow rate and pressure of the media 155delivery from the pump 236. The pump 236 can have a pump outlet 240configured to deliver pressurized media 155. The pump outlet 240 canconnect to the pressurization release check valve 188. The pump powerswitch 238 can be turned to an on position. The motorized air pump 236can then deliver pressurized media 155 through the pressurizationrelease check valve 188 and into the outer catheter distal tip 78. Thepressurized media 155 can, for example, inflate, expand, advance,propel, and evert the everting balloon 18.

The pump 236 can deliver air or other media 155 directly into theeverting balloon 18. The air pump 236 can be connected to the base ofthe everting balloon 18. The distal tip of the everting balloon 18 canbe placed at the urethral opening.

The pump 236 can be configured to stall, a pressure relief valve, orother pressure check valve mechanism can open, or combinations thereof,if the pump outlet 240 pressure exceeds a maximum pressure limit of theeverting balloon 18.

After pressurization of the everting balloon 18, the pump 236 can bedisconnected from the pressurization release check valve 188, forexample by the depression of a release button or can automatically bedisengaged upon stalling the pump 236 or by the activation of thepressure relief valve within the air pump. The increase of pressurewithin the everting balloon 18 can automatically disconnect the air pumpfrom the everting balloon 18 and/or pressurization release check valve188.

The outer catheter distal tip 78 (i.e., the base of the everting balloon18) can be small and made from a soft durometer material, with a shallowprofile for comfortable wearing for the patient. The outer catheterdistal tip 78 can have a rounded, smooth, domed, or disk-like shape. Theouter catheter distal tip 78 can have a pillow-like feel. The outercatheter distal tip 78 can be manufactured with two molded halves withan internal, circumferential attachment ring.

The pressurization release check valve 188 can be engaged to the pump236 with an internal locking ring that can be disengaged either througha manual actuator or automatically as described above.

The everting balloon system 2 can have a pressure indicator. Thepressure indicator can indicate (e.g., via a light, buzzer, mechanicalindicator such as a compliant dimple) if the desired pressure is notachieved, for example signifying a leak in the everting balloon system2. The user can be alerted that the everting balloon system 2 is notpatent and should not be relied upon for effectiveness (e.g., urinarycontrol).

The pump 236 can be a reusable, small profile, battery operated, airpump. The pump 236 can allow for insertion and control of the evertingballoon 18 and outer catheter distal tip 78 at the urethra 218,inflation of the everting balloon 18, and can be disengaged from theeverting balloon 18 automatically or through a push button control orother actuator. As an example, the air pump 236 can have a check valvefor pressure relief at or below about 380 mmHg (0.5 atm) or about 7 psi(0.5 atm), for example, for inflation and sealing during exercise,coughing, and other pelvic floor movements by the user.

The air pump 236 can be washed and replaced after a predetermined numberof uses or applications before an internal battery is expended orreplaced. The everting balloon 18 can be mounted onto the distal end ofthe air pump 236, for example on or around the pump outlet 240.

The air pump 236 can provide be operated with no manual manipulations bythe user for inflation or locking air pressure. The air pump 236 can bequiet and water-tight, for example to prevent leaking into the pump 236during cleaning.

The pump 236 can be connected to the everting balloon 18 or outercatheter distal tip 78 by a section of tubing, for example to providestrain relief or more degrees of freedom in terms of insertion angle ofthe everting balloon 18. The air pump 236 attached to the evertingballoon 18 can be delivered to the target site 164 with one hand.

The inflation device can be or have a prefilled gas canister or ampule.The canister can be carbon dioxide (CO2) or nitrous oxide capsules.

The everting balloon 18 can be pressurized with liquid (hydraulic)and/or gas (pneumatic) pressure. Liquid, such as water or saline, can belubricous and incompressible. The liquid can deliver a higher traversingforce for the everting balloon than a gas. Gas, such as carbon dioxide,nitrous oxide, nitrogen, or air, can be lighter than liquid.

The external surface of the everting balloon 18 and/or outer catheterdistal tip 78, for example the areas interfacing the urethra 218, can becoated or covered by conformable protrusions, gel or jelly, anadhesive-like covering, for example to secure to the target body lumenwall and prevent leaks, or combinations thereof. The coating on theexternal surface of the everting balloon 18 can have anti-bacterialand/or anti-infection properties and/or agents to reduce the potentialfor infection. The coating can contain anesthetic and analgesicproperties or agents (e.g. lidocaine) to reduce discomfort and/or otherdrugs, therapeutic agents, compounds, or combinations thereof. Theexternal surface of the everting balloon 18 and/or outer catheter distaltip 78, for example the areas interfacing the urethra 218, can beconformable and soft, for example to fill the target body lumen.

The everting balloon 18 can be sterile before eversion. For example, allportions of the everting balloon 18 can be contained inside the basewhen the system is positioned adjacent to the opening of the urethra218. The distal outer catheter tip 78 can be contained within aninsertion tube during the insertion process.

Deployment of the everting balloon 18 can be atraumatic. For example,the everting balloon 18 can roll inside the body lumen (e.g., urethra)without any translational (i.e., shear) or frictional forces on thelumen wall.

The patient can keep and store additional everting balloon 18 and outercatheter distal tips 78 on their person.

As shown for example in FIGS. 13A through 18B, the outer catheter distaltip 78 does not need to attach to a catheter to be used. The outercatheter distal 78 tip can be used by attaching to a pressurized media155 source (e.g., a catheter, syringe, pump, or combinations thereof),force delivery element (e.g., a plunger), having an on-board pressuresource in the outer catheter distal tip 78, or combinations thereof. Theouter catheter distal tip 78 is also referred to as the base.

After the everting balloon system 2 is pressurized and positioned in thecervix, the inner catheter 8 can be distally advanced toward the targetbody cavity by hand or with a one-handed control system, such as thesystem handle 30. The system handle 30 can allow the user to hold theentire catheter system and manipulate the pressurization, movement ofcomponents, and de-pressurization of the balloon membrane 6 with onehand. The user can then utilize the other hand for the manipulation ofinstruments, controlling ultrasound, handling visualization techniques,depositing materials within the through-lumen by use of another syringeor delivery device mechanism, or combinations thereof.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. “Dilation” and “dilatation” are usedinterchangeably herein. The media 155 delivered herein can be any of thefluids (e.g., liquid, gas, or combinations thereof) described herein.The patents and patent applications cited herein are all incorporated byreference herein in their entireties. Some elements may be absent fromindividual figures for reasons of illustrative clarity. Theabove-described configurations, elements or complete assemblies andmethods and their elements for carrying out the disclosure, andvariations of aspects of the disclosure can be combined and modifiedwith each other in any combination. All devices, apparatuses, systems,and methods described herein can be used for medical (e.g., diagnostic,therapeutic or rehabilitative) or non-medical purposes.

We claim:
 1. A system for accessing a cervical canal adjacent to auterine cavity comprising: a first catheter; a second catheter radiallyinside in the first catheter, wherein the second catheter istranslatable with respect to the first catheter; a first balloonattached at a first end to the first catheter, and wherein the firstballoon is attached at a second end to the second catheter; and a secondballoon attached to the second catheter; wherein the second balloon isat least partially within the first balloon.
 2. The system in claim 1,wherein the second balloon is configured to inflate within the firstballoon and tear the first balloon.
 3. The system in claim 2, whereinthe first balloon comprises an everting balloon and the second ballooncomprises a dilating balloon.
 4. The system in claim 1, wherein thefirst balloon comprises an intention tear line, and wherein theintention line is configured to tear.
 5. The system in claim 4, whereinthe intention line in the first balloon comprises a mechanicalindentation or seam.
 6. The system in claim 1, wherein the firstcatheter comprises a mechanical instrument configured to tear the firstballoon.
 7. The system in claim 6, wherein the mechanical instrument ison the first catheter.
 8. The system in claim 6, wherein the mechanicalinstrument is within the first catheter.
 9. The system in claim 8,wherein the mechanical instrument is configured to activate upon fulleversion and inflation of the dilating balloon.
 10. The system in claim2, wherein the second catheter comprises a sharp implement for tearingthe eversion balloon, and wherein the sharp implement is configured tobecome active upon full eversion and inflation of the dilating balloon.11. The system in claim 2, wherein the second catheter is configured todisengage the eversion balloon at the distal end of the second catheterupon inflating the dilating balloon.
 12. The system in claim 2, whereinthe eversion balloon comprises an eversion balloon material, and whereina molecular structure of the eversion balloon material has an increasedlongitudinal axial orientation to promote a longitudinal break when theeversion balloon tears.